Bone Mineral Density Clause Samples

The 'Bone Mineral Density' clause defines the standards or requirements related to the measurement and assessment of bone mineral density, typically in the context of clinical trials, medical studies, or healthcare agreements. This clause may specify the methods to be used for measuring bone density, such as DEXA scans, and outline the frequency or timing of these assessments for study participants. Its core practical function is to ensure consistency and reliability in how bone health is evaluated, thereby supporting accurate data collection and analysis or meeting regulatory and safety requirements.
Bone Mineral Density. To be eligible for randomization and entry into the Treatment Period, each patient must have a BMD T-score < -2.5 and > -5.0 at the lumbar spine or hip by dual energy x-ray absorptiometry (DXA). Postmenopausal women older than 65 who meet the fracture criteria but have a T-score < -2.0 and > -5.0 may be enrolled as well as women older than 65 who do not meet the fracture criteria but who do have a T-score <-3.0 and > -5.0. All patients will have BMD measurements taken via DXA during the Screening (Visit 1) and Pretreatment (Visit 2) Periods and during the Treatment Period (Visits 6, 8 and 9). However, in the event that qualifying BMD scans have been obtained as a consequence of routine patient care within 3 months prior to the Screening visit and comply with the study DXA procedures, such scans may be used for assessment of eligibility and need not be redone at Screening. The initial DXA will be performed during the Screening Period and will be used to determine eligibility for participation in the study in conjunction with the radiological evaluations of fractures. The DXA is to be performed on the hip (femoral neck) and spine (L1-L4) at this visit and a qualifying T-score from either location can be used to determine eligibility. The spinal DXA is to be taken in the postero-anterior projection with any subsequent spinal DXA to be taken in the same projection. Patients who meet the entry criterion for BMD who satisfy all other eligibility criteria, and who have no exclusionary findings, will then be enrolled. On Day 1, a subset of 300 patients per group will have a wrist DXA scan. BMD measurements by DXA will be repeated at the lumbar spine (L1-L4), hip, and wrist during the Treatment Period (Visits 6, 8 and 9). Details regarding the procedures for the conduct and processing of DXA scans will be provided in separate instruction manual. Patient eligibility will be determined based on local analysis of the BMD scan at the study site. The Central Imaging CRO will subsequently confirm the acceptability of each DXA scan with the study sites. If any scan is unacceptable for technical or other reasons, a repeat scan must be completed as soon as possible. Investigators will be blinded to the results of all follow-up DXA scan results throughout the study unless a safety issue is identified by the independent radiologist. If the independent radiologist identifies any patient who shows a continuing significant deterioration from baseline (>7%) of BMD at spine or hip...
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Bone Mineral Density. All subjects will have bone mineral density measurements (BMD) taken via DXA at Month 6 and at Month 24. The End-of-Treatment (Visit 9) bone mineral density tests for Study BA058-05-003 will serve as the baseline BMD measurements for Study BA058-05-005. DXAs will be performed on the hip (femoral neck) and spine (L1-4). The spinal DXA is to be taken in the postero-anterior (PA) projection with any subsequent spinal DXA to be taken in the same projection. Subjects who underwent wrist DXAs in Study BA058-05-003 will also have wrist DXAs performed at Month 6 and Month 24. The same side of the hip and wrist that were used in Study BA058-05-003 must be used for the DXA scan, and the same scanner should be used throughout the study, when possible.
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Bone Mineral Density. All subjects will have bone mineral density measurements (BMD) taken via DXA at Months 6, 12, 18, and 24. The End-of-Treatment (Visit 9) bone mineral density tests for Study BA058-05-003 will serve as the baseline BMD measurements for Study BA058-05-005. DXAs will be performed on the hip (femoral neck) and spine (L1-4). The spinal DXA is to be taken in the postero-anterior (PA) projection with any subsequent spinal DXA to be taken in the same projection. Subjects who underwent wrist DXAs in Study BA058-05-003 will also have wrist DXAs performed at Months 6, 12, 18, and 24. The same side of the hip and wrist that were used in Study BA058-05-003 must be used for the DXA scan, and the same scanner should be used throughout the study, when possible. If the independent radiologist identifies any patient who shows a continuing significant deterioration from the Day 1 assessment of Study BA058-05-005 (>7%) of BMD at spine or hip during the study, the study physician will be notified, the assessment will be repeated and, if confirmed, the patient will be discontinued from the study. The study physician will make this determination on the basis of the centrally read DXA relative to the baseline measurement in consultation with the Sponsor Medical Monitor.
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